Levosimendan

Drug Profile

Levosimendan

Alternative Names: Daxim; ODM 109; OR-1259; Oral levosimendan - Orion; Simdax

Latest Information Update: 29 Nov 2016

Price : $50

At a glance

  • Originator Orion
  • Developer Abbott Laboratories; AbbVie; Imperial College of Science, Technology and Medicine; Orion; Tenax Therapeutics
  • Class Antiarrhythmics; Cardiotonics; Hydrazones; Nitriles; Pyridazines; Small molecules; Vasodilators
  • Mechanism of Action Calcium-binding protein modulators; Calcium-sensitising phosphodiesterase inhibitors; Potassium channel agonists; Type 3 cyclic nucleotide phosphodiesterase inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    Low cardiac output
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Acute heart failure
  • Phase III Low cardiac output
  • Phase II Amyotrophic lateral sclerosis
  • Discontinued Chronic heart failure; Myocardial infarction; Septic shock; Stroke; Transient ischaemic attacks

Most Recent Events

  • 29 Nov 2016 Tenax Therapeutics initiates expanded access for Acute heart failure (In neonates, In infants, In children, In adolescent) in USA (NCT02973620)
  • 18 Nov 2016 Tenax Therapeutics completes enrolment in the phase III LEVO-CTS trial for Low cardiac output in USA and Canada
  • 10 Nov 2016 Tenax Therapeutics announces intention to submit NDA to US FDA
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